unit 2: republic act 4688

Republic Act 4688

• Clinical Laboratory Law

• Comprised of eight (8) sections only

• Approved on June 18, 1966

Section 1

Any **person, firm or corporation, operating and maintaining a clinical laboratory** in which body fluids, tissues, secretions, excretions and radioactivity from humans or animals are analyzed for the determination of the presence of pathologic organisms, processes and/or conditions in the persons or animals from which they were obtained, **shall register and secure a license** __**annually**__ **at the office of the Secretary of Health**

government hospital laboratories doing routine or minimum laboratory examinations

**Section 1:**

shall be **exempt** from the provisions of this section if their services are extensions of government regional or central laboratories

**Section 2**

It shall be **unlawful** for __any person to be professionally in-charge of a registered clinical laboratory__ unless **he is a licensed physician duly qualified in laboratory medicine and authorized by the Secretary of Health**, such authorization to be **renewed annually**

such laboratory is under the administration, direction and **supervision of an** __**authorized physician**__

**Section 2:**

**No license shall be granted or renewed** by the Secretary of Health for the operation and maintenance of a clinical laboratory unless

**Section 3**

The **Secretary of Health**, through the Bureau of Research and Laboratories shall be charged with the **responsibility of strictly enforcing the provisions** of this Act and **shall be authorized to issue such rules and regulations** as may be necessary to carry out its provisions

Section 4

Any person, firm or corporation who **violates** any provisions of this Act or the rules and regulations issued thereunder by the Secretary of Health **shall be punished**

not less than **one month** but not more than **one year**

**Section 4:**

imprisonment

not less than **one thousand pesos** nor more than **five thousand pesos**

**Section 4:**

fine

**Section 5:** Separability clause

If any section or part of this Act shall be adjudged by any court of competent jurisdiction to be **invalid**, the judgment shall not affect, impair, or invalidate the remainder thereof

fifty thousand pesos

**Section 6:**

The sum of ___, or so must thereof as may be necessary, is hereby authorized to be **appropriated**, out of any funds in the National Treasury

**Section 7:** Repealing clause

All Acts or parts of Acts which are **inconsistent** with the provisions of this Act are hereby repealed.

**Executive Order No. 102, Series of 1999**

Redirecting the Functions & Operations of DOH

Administrative Order No. **59**, Series of **2001**

Rules & Regulations Governing The Establishment, Operation & Maintenance of Clinical Laboratories in the Philippines

Administrative Order No. **2007-00**__**27**__

**Revised** Rules and Regulations Governing the Licensure and Regulation of Clinical Laboratories in the Philippines

Administrative Order No. **2008-000**__**2**__

**Posting of Schedule of Fees** for Laboratory and Other Diagnostic Services of Hospitals and other Health Facilities

Administrative Order No. **2008-000**__**7**__

**Schedule of Fees** for the Licensure of General Clinical Laboratories and the Registration of Special Clinical Laboratories

Administrative order No. **2021-00**__**37**__

**New** Rules and Regulation Governing the Regulation of Clinical Laboratories in the Philippines

**Health Facilities and Service Regulatory Bureau** (HFSRB)

• specific department of DOH in-charge of licensing and regulation of all health facilities including Clinical Laboratories

• formerly BHFS (Bureau of Health Facilities & Services)

Applicant

**Definition of Terms:**

natural or juridical **person** who intends to operate a clinical laboratory

CHD

**Definition of Terms:**

Center for Health Development

Clinical Laboratory

**Definition of Terms:**

**facility** where tests are done on specimens from human body to obtain information about health status of patient for prevention, diagnosis and treatment of diseases

Critical Values

**Definition of Terms:**

panic values originally described by Lundberg as "**life-threatening**" unless something is done promptly and for which some corrective action could be undertaken

EQAP

**Definition of Terms:**

**External Quality Assessment Program**; program where participating laboratories are **given unknown samples** for analysis

Assessment Tool

**Definition of Terms:**

**checklist** used by regulatory officers **during inspection visits** to evaluate compliance of clinical laboratory to minimum standards and technical requirements

AO 2021-0037 **Annex B1**

**Definition of Terms:**

**ASSESSMENT TOOL** FOR LICENSING A GENERAL CLINICAL LABORATORY

AO 2021-0037 **Annex B2**

**Definition of Terms:**

**EQUIPMENT**/INSTRUMENT S/GLASSWARE/SUPPLIES/ REAGENTS **PER AREA OF ACTIVITY**/SERVICE CAPABILITY OF GENERAL CLINICAL LABORATORY

AO 2021-0037 **Annex C**

**Definition of Terms:**

**PROHIBITED ACTS** IN THE OPERATIONS OF CLINICAL LABORATORIES

AO 2021-0037 **Annex D1**

**Definition of Terms:**

PLANNING AND DESIGN **GUIDELINES** FOR GENERAL CLINICAL LABORATORY

AO 2021-0037 **Annex D2**

**Definition of Terms:**

**CHECKLIST FOR REVIEW OF FLOOR PLANS** GENERAL CLINICAL LABORATORY

AO 2021-0037 **Annex E**

**Definition of Terms:**

GUIDELINES IN SECURING FOR **REMOTE COLLECTION** PERMIT FOR CLINICAL LABORATORIES

AO 2021-0037 **Annex F**

**Definition of Terms:**

**APPLICATION FORM FOR CERTIFICATE** OF REGISTRATION FOR RESEARCH AND TEACHING CLINICAL LABORATORY

Institution

**Definition of Terms:**

corporate body or **establishment** organized for an **educational, medical, charitable or similar purpose**

License

**Definition of Terms:**

**issued by DOH** to an individual, agency, partnership or corporation **that operates a clinical laboratory** upon compliance with the requirements set forth

Licensee

**Definition of Terms:**

individual, agency, partnership or corporation to whom the **license is issued and upon whom rests compliance**

Mobile Clinical Laboratory

**Definition of Terms:**

**laboratory testing unit that moves from testing site to another testing site**, or has a **temporary** testing location; shall have a __base laboratory__

Monitoring Examinations

**Definition of Terms:**

tests **done in series on patients** as a guide for treatment or follow-up of their condition

NRL (**National Reference Laboratory**)

**Definition of Terms:**

laboratory in a government hospital designated by DOH **to provide special functions and services for** __**specific**__ **disease areas**

POL (**Physician’s Office Laboratory**)

**Definition of Terms:**

individual doctor's office/ **clinic** wherein laboratory examinations are performed

POCT (**Point of Care Testing**)

**Definition of Terms:**

**diagnostic testing at or near the site of patient care** rather than in clinical laboratory; includes bedside testing, outpatient and home care

Routine Tests

**Definition of Terms:**

**basic, commonly requested tests** in the laboratory, the results of which are not required to be released immediately upon completion

Satellite Testing Site

**Definition of Terms:**

any testing site that **performs laboratory examinations** __under the administrative control of a licensed laboratory__, but **performed outside the physical confines** of that laboratory

STAT Tests

**Definition of Terms:**

done on **urgent cases**, results of which shall be released immediately, within **one (1) hour after the procedure.**

Regulations, Licensing, and Enforcement Division (RLED)

**Definition of Terms:**

A division at the Center for Health Development (CHD) **responsible for the issuance** of Certificate of Need, Permit to Construct, License to Operate/Authority to Operate, and the **conduct monitoring of hospital and health facilities**

Permit to Construct

**Definition of Terms:**

a **permit** issued by DOH to an **applicant who will establish and operate** a hospital or other health facility, upon compliance with required documents; **required for hospitals and other health facilities** with __substantial alteration, expansion, renovation, or for additional services (add-ons)__ beyond their service capability

Initial Application

**Definition of Terms:**

refer to **applications by newly constructed health facilities**, or those **with changes in the circumstances of the facility**, such as, but not limited to, change of ownership, transfer of site, increase in beds or for additional services beyond their service capability and major alterations or renovation

**National External Quality Assessment Scheme** (NEQAS)

**Definition of Terms:**

an **EQAP activity** conducted by the National Reference Laboratories to **assess the quality of performance and accuracy of the results** of laboratories.

Referral Tests

**Definition of Terms:**

refers to **CL tests that are either sent-out or outsourced to other DOH-licensed CL** with the same or higher service capability.

**National Kidney and Transplant Institute** (NKTI)

National Reference Laboratories:

• Hematology

• Immunohematology

• Urinalysis

**STD/AIDS Central Cooperative Laboratory** (SACCL)

**National Reference Laboratories:**

* Serology

**Lung Center of the Philippines** (LCP)

**National Reference Laboratories:**

* Clinical Chemistry

**East Avenue Medical Center** (EAMC)

National Reference Laboratories:

• Drug Testing

• Water Microbiology

• Micronutrient Assay

**Research Institute of Tropical Medicine** (RITM)

National Reference Laboratories:

• Microbiology

• Parasitology

Government

**Classification of Laboratories:** *By Ownership*

operated and maintained, partially or wholly, **by the national government, a local government unit** (provincial, city or municipal), any other political unit or any department, division, board or agency thereof

Private

**Classification of Laboratories:** *By Ownership*

**privately owned**, established and operated with funds through donation, principal, investment or other means, by any individual, corporation, association or organization

**Clinical** Pathology

Classification of Laboratories: By Function

• deals with the chemical and cellular analyses of blood and other body fluids

• Clinical Chemistry, Hematology, Immunohematology, Microbiology, Immunology, Clinical Microscopy, Endocrinology, Molecular Biology, Cytogenetics, Toxicology and Therapeutic Drug Monitoring

**Anatomical** Pathology

Classification of Laboratories: By Function

• provides processing and examination of surgical specimens as to the physical appearance and microscopic structure of tissues

• Surgical Pathology, lmmunohistopathology, Cytology, Autopsy, Forensic Pathology and Molecular Pathology

**Molecular** Pathology

**Classification of Laboratories:** *By Function*

* deals with the **analysis of certain genes, proteins and other molecules** in samples from organs, tissues or bodily fluids in order to diagnose disease

Institution-based

Classification of Laboratories: By Institutional Character

• a laboratory that operates within the premises and as part of an institution, such as but not limited to hospital, medical clinic, school, medical facility for overseas workers and seafarers, birthing home, psychiatric facility, drug rehabilitation center

• A laboratory that is located within the premises and operates as part of a DOH licensed health facility.

Free-standing/Non-institutional based

Classification of Laboratories: By Institutional Character

• a laboratory that does not form part of any other institution

• A laboratory that operates independently and is not attached to any DOH licensed health facility.

Primary

(AO 2007-0027) Classification of Laboratories: By Service Capability: General CL

• Routine Hematology

  • Complete Blood Count

    • Hemoglobin

    • Hematocrit

    • WBC Count

    • WBC Differential Count

• Qualitative Platelet Determination

• Routine Urinalysis

• Routine Fecalysis

• Blood Typing (hospital based)

• Clinical Microscopy

• Clinical Chemistry

• Serology/Immunology

• Microbiology

**AO 2021-0037:**

Primary Laboratory additions

Secondary

(AO 2007-0027) Classification of Laboratories: By Service Capability: General CL

• Routine Clinical Chemistry

  • Glucose

  • Blood Urea Nitrogen

  • Uric Acid

  • Creatinine

  • Total Cholesterol

• Quantitative Platelet Determination

• Cross Matching (hospital based)

• Gram Staining (hospital based)

• KOH (hospital based)

Tertiary

(AO 2007-0027) Classification of Laboratories: By Service Capability: General CL

• Special Chemistry

• Special Hematology, including coagulation procedures

• Immunology

• Microbiology

  • Culture & Sensitivity

  • Aerobic & Anaerobic (for hospital based)

  • Aerobic or Anaerobic (for non-hospital based)

Limited Service Capability

**Classification of Laboratories:** *By Service Capability:* __*General CL*__

Provides laboratory **tests required for a particular service** in institutions such as but not limited to dialysis centers and social hygiene clinics

Clinical Laboratory for **Anatomic Pathology**

**Classification of Laboratories:** *By Service Capability:* __*General CL*__

provides services for any of the following, but not limited to: **cytology and histopathology**

Clinical Laboratory for **Molecular Pathology**

**Classification of Laboratories:** *By Service Capability:* __*General CL*__

provides services for **genetics, immuno/hematopathology and infectious disease**. COVID-19 testing laboratories shall be covered by another order.

Clinical laboratories **exclusive for research and teaching purposes**

**General Guidelines:**

shall be **exempted** from the licensing requirement but shall be required to register

• Assisted Reproduction Technology

• Molecular & Cellular Technology

• Molecular Biology

• Molecular Pathology

• Forensic Pathology

• Anatomic Pathology

**General Guidelines:** *Special Laboratories*

**license of clinical laboratory** of the hospital

**General Guidelines:**

**NRL** shall be covered by ___

required

**General Guidelines:**

**POL** ___ to secure a LTO

management of clinical laboratory

**General Guidelines:**

POCT (in hospital) required under ___

Pathologist

Specific Guidelines: Human Resources

• Head of Laboratory

• shall have administrative and technical supervision of the activities in the laboratory

**workload and service**s being provided

**Specific Guidelines:** *Human Resources*

* number of staff shall depend on ___

Rotation 24-hour duty

**Specific Guidelines:** *Human Resources*

Microscopy, Hematology, Clinical chemistry

minimum of 8, maximum of 12

**Specific Guidelines:** *Human Resources*

Working hours

50 tests

**Specific Guidelines:** *Human Resources*

Manual testing: 8 hours

75 tests

**Specific Guidelines:** *Human Resources*

Manual testing: 12 hours

100 tests

**Specific Guidelines:** *Human Resources*

Automated testing: 8 hours

150 tests

**Specific Guidelines:** *Human Resources*

Automated testing: 12 hours

10 sq m

**Specific Guidelines:** *Physical Facilities:* __*Minimum Technical Working Area*__

Primary

20 sq m

**Specific Guidelines:** *Physical Facilities:* __*Minimum Technical Working Area*__

Secondary

60 sq m

**Specific Guidelines:** *Physical Facilities:* __*Minimum Technical Working Area*__

Tertiary

Satisfactory performance rating

**Specific Guidelines:** *Physical Facilities:* __*Quality Control Program*__

criteria for **renewal of license**

Refusal to participate in EQAS-NRL

**Specific Guidelines:** *Physical Facilities:* __*Quality Control Program*__

basis for **suspension/revocation of license**

Reporting

Specific Guidelines: Physical Facilities

• Bear the name and signature of Pathologist & RMT

• No report orally or in writing without directive from pathologist or associate except in emergency cases

Recording

Specific Guidelines: Physical Facilities

• All requests and reports of all specimens submitted and examined

• Kept in file for at least 1 year

kept permanently

**Specific Guidelines:** *Physical Facilities:* __*Recording*__

Anatomic and forensic pathology reports

**One-Stop-Shop** Licensure System

**Renewal of LTO:**

Hospitals

first day of October to last day of November

**Renewal of LTO:**

Non-hospitals: **discount** on renewal fee if application completed during this period

5 working days

**Renewal of LTO:**

processed not later than ___ after expiration date of LTO

automatically **cancelled without notice**

**Renewal of LTO:**

LTO ___ when failure to submit a duly accomplished application form and to pay proper fee on or before the expiration date stated in license

accessibility of premises and facilities for inspection

**Inspection**:

Licensee shall ensure ___ of CHD Director or authorized representative(s) at any reasonable time

availability of all pertinent records for checking/review

**Inspection**:

Licensee shall ensure ___ of CHD Director or his authorized representative(s)

Refusal

**Violations:**

___ on any clinical lab to participate in EQAP

Issuance of a report, orally or in writing

**Violations:**

___ (in whole or part thereof) which is not in accordance with documented procedures

perform technical procedures

**Violations:**

Permitting **unauthorized persons** to ___

Deviations

**Violations:**

___ from standard test procedure

unlicensed laboratory

**Violations:**

Lending or using the name of licensed laboratory or head or RMT to an ___

secure LTO

**Violations:**

**Unauthorized use of the name and signature of Pathologist and RMT** to ___